1. Field of the Invention
The present invention relates generally to devices for compressing the breasts of a woman and, more specifically, to a device which is able to support a breast of a woman and provide a compression force in a controlled even manner on either side of the breast for relieving the effects of Capsular Contracture.
The function of the present invention is to provide patients after breast reconstruction following mastectomy or breast augmentation, an in-house device to prevent capsular contracture. The Breast Compression Device will be increasing breast implants surface area during the compression cycles by changing the shape of the implant from a substantially spherical to elliptical shape and thereby stretching the periprosthetic contracting scar. While the use of this device will vary according to the individual the normal application will consist of a number or repetitions of 10 seconds of pressurization and 10 seconds of rest.
2. Description of the Prior Art
Capsular Contracture is a common complication following such surgeries. When tissue is injured, the body tries to repair the defect by generating new blood vessels at the periphery of the injury by secreting collagen to form a new tissue matrix. Often the blood vessels regress leaving excess collagen to form scar tissue. After breast augmentation and breast reconstruction surgeries, excess collagen scar tissue result in spherical Capsular Contracture that surrounds the breast implant causing significant discomfort, pain, distortion and displacement of the implant.
There are three basic treatments for Capsular Contracture. In the technique known as Closed Capsulotomy, the doctor squeezes the hardened tissue in order to break it. Implant manufacturers do not recommend this procedure because this abnormal and uncontrolled force can result in hemorrhaging and can rupture the implant. In Open Capsulotomy, the doctor surgically breaks up the scar tissue. In Capsulotomy, the scar tissue is surgically removed. With all three treatments, even if Capsular Contracture is relieved, it might recur,- warning Dow Coming, Implant Information Booklet.
Many doctors recommend continuous manual self-compression of the breast for several months after surgery in order to prevent Capsular Contracture. The disadvantage of manual compression is the force that the patient is capable of producing is not linear safety and effectiveness.
Numerous types of devices for compressing and supporting a breast of a woman have been provided in the prior art. For example, U.S. Pat. Nos. 4,202,343; 5,050,595;5,823,851;5,891,070;5,904,607;5,950,238; 5,968,003 and 6,022,317 all are illustrative of such art.
A brassiere comprising a body encircling band having a pair of breast cups and shoulder straps, and a pair of midriff straps secured at the bottom of the breast cups to a waist encircling garment such as a belt or shorts, the midriff straps being used to urge the breast downwardly to prevent undo movement thereof while jogging. In an alternate brassier, the shoulder straps cross at the wearers back, pass through loops at the side and extend upwardly to where they are secured to the lower portion of the breast cups, the loops being secured to the waist encircling garment.
A women therapeutic support garment comprising a pair of breast supporting cups each of which is formed with an inner and outer panel defining therebetween one of two cupped shaped pockets. A cup shape, thermal gel pack is placed in each pocket and has a central opening for accommodation the women nipple. A pair of side panels are connected to the breast supporting cups, the side panels being dimensioned and configured to encircle the wearer and hold the breast supporting cups in place with the gel packs surrounding the women breast. The heat from each gel pack serves to reduce swelling and tenderness of the breast tissues during the premenstrual period, pregnancy or the post-pardem period.
A bra sport top provides enhanced posture and increased breast support for women engaging in athletic activities. Over-shoulder harness encircle each shoulder and serve to urge them back. Cross braces interconnect the two over-shoulder harnesses in a crosswise manner between the shoulder blades. A support belt traveling through a slip sleeve encircling the wearer""s torso below the breast and shoulder blades. Interconnecting the over-shoulder harnesses and the slip sleeve are breast tensioning panels that compress and retrain the breast so as to prevent any damage to the breast tissue. The left and right breast-tensioning panels may be interconnected by a detachable coupling means or may be connected by elastic bands or the like. Alternative embodiments allow for different directional support of the underlying breast tissue by the breast-tensioning panels.
A breast presser belt comprising a belt body adapted to be removably wrapped around a breast portion of a user, a presser member adapted to extend from the belt body over the breast portion of the user, and a bag adapted to be inflated by means of appropriate fluid. The bag is attached to the inner surface of the presser member at a predetermined position. When the bag is inflated, the breast presser belt pressurizes the breast portion of a user and securely fastened to the breast portion. Thus, the pressurizing location of the breast presser belt is prevented from being shifted. The breast pressure belt does not require a user or patient to keep still on a bed. Allergic poisoning, previously experienced due to the use of medical adhesive tape may be obviated. The breast presser belt may be applied to a female having breast.
A two component post-operative compression garment for use in enhancing fluid drainage from a plurality of open micro-incisions in breasts after liposuction surgery has been performed on breasts. The compression garment includes a first garment component positionable on a person to cause a first magnitude of compression pressure upon the breasts, and a second garment component adjustably positionable in concert with the first garment component to cause an adjustable second magnitude of compression pressure greater than the first magnitude. This second magnitude of pressure is adjustable to thereby provide a pressure adequate to force fluid from the open micro-incisions of the breasts. Methodology of liposuction mammoplasty includes infiltrating each breast tumescently with a fluid that includes a local anesthetic. Thereafter, a plurality of micro-incisions are provided to the breast and fatty tissue is withdrawn suctionally with operating microcannulas inserted within the micro-incisions. Finally, the micro-cannulas are removed from the open micro-incisions and compression pressure is applied as with the above described compression garment to each breast for a period of time and of sufficient pressure to force the tumescent fluid from the breasts through the micro-incisions. Substantially identical liposuction methodology can be employed for abdominal areas.
A compression bandage according to the present invention includes an expandable band that overlaps a post-operative breast to support and provide secondary compression, and compression flaps each having first and second ends, the first ends being connected to the expandable band adjacent the area to be compressed and the second ends being securable. The compression flaps compress the post-operative breast when longitudinally extended, and maintain the compression when the second ends are fastened. The compression bandage further comprises a least one shoulder support or strap connected to the expandable band to reduce movement of the bandage. The compression bandage can also have a support belt attached to the expandable band for supporting the area to be compressed.
The invention refers to equipment for the generation of ultrasonic waves with regulation of the frequency and power range with two possibilities of working, in continuous or pulsating modes, to be transmitted by adequate means to the transducer. The invention discloses a supporting means such as a harness or similar. Said harness is directly applied on the breast with capacity to act on the same in a selective way by programming the amount of power to be transmitted to transducers in an individualized form. The invention permits the elimination of capsular contractures corresponding to degree IV in the scale.
While these units may be suitable for the particular purpose to which they address, they would not be as suitable for the purposes of the present invention as heretofore described.
It is therefore desirable to provide a breast compressing device able to using lateral breast compression to mechanically distort the implant into a stretched ovoid shape, in a controlled manner, thereby increasing its surface to volume ratio. It is further desirable to provide a breast compressing device which will stretch the periprosthetic scar tissue that is the potential source of Capsular Contracture. It is even further desirable to provide a breast compressing device able to significantly reduce the risk of developing spherical Capsular Contracture. It is still further desirable to provide a breast compressing device able to apply a compressive force of a range of magnitude (safe and therapeutically effective at the same time) determined through clinical studies with real patients in different stages of rehabilitation after surgery during manual self-compression. The Data Acquisition System used in these studies was specifically designed for the purpose of developing the breast compression device.
The present invention relates generally to devices for compressing the breasts of a woman and, more specifically, to a device which is able to support a breast of a woman and provide a compression force in a controlled even manner on either side of the breast for relieving the effects of Capsular Contracture.
A primary object of the present invention is to provide a breast compressing device that will overcome the shortcomings of prior art devices.
Another object of the present invention is to provide a breast compressing device which is able to mechanically compress a breast of a woman and any implant within the breast in a controlled manner.
A further object of the present invention is to provide a breast compressing device which is able to be selectively used in the privacy of ones home.
A yet further object of the present invention is to provide a breast compressing device including an adjustable harness for securing the device about the body of the user and adjusted to fit various body sizes.
A still further object of the present invention is to provide a breast compressing device including an aperture for receiving the breast therein, supporting the breast and restricting movement of the breast.
Another object of the present invention is to provide a breast compressing device including horizontal and vertical adjustment elements for varying the size of the aperture.
An even further object of the present invention is to provide a breast compressing device having controllable opposing extendable and retratable compression elements and a pump for extending and retracting the opposing compression elements.
A yet further object of the present invention is to provide a breast a breast implant compression device having compression housing members which laterally extend upon application of a controllable pressure.
Another object of the present invention is to provide a breast a breast implant compression device wherein the compression housing members are connected by a common conduit to a source of air pressure.
An even further object of the present invention is to provide a breast implant compression device wherein the air pressure is applied to the compression elements by a hand held mechanical, electromechanical, or electronically controlled pump having a pressure gauge.
A still further object of the present invention is to provide a breast implant compression device able to increase breast implant surface area during compression cycles thereby stretching periprosthetic scar tissue, and therefore, preventing Capsular Contracture.
Another object of the present invention is to provide a breast compressing device that is simple and easy to use.
A yet further object of the present invention is to provide a breast compressing device that is economical in cost to manufacture.
Additional objects of the present invention will appear as the description proceeds. The breast compression device of the present invention provides numerous features and benefits. Some of the features and benefits are as follows:
Functional Features
1. The Breast Compressor Device applies a controlled, lateral compression equally to both sides of the breast to mechanically distort the implant into a stretched ovoid shape;
2. Operation of the Device is automatic, only requiring the user to turn it on;
3. The Device measures and monitors the applied pressure for proper control of the compression force delivered to the breast.
Performance Features
1. When activated, the device preferably applies a compression force for 10-20 seconds, followed by 5-10 seconds of relaxation. The compression time and relaxation time being adjustable and the preferred adjustable session time being 15 minutes for each breast;
2. The device is quiet and therefore not intrusive in a home environment;
3. The device operates for a minimum of 30 minutes without needing a battery recharge, battery recharge time being approximately 4 hours or less with a charger powered from 120 volts AC.
Physical Features
1. The breast compression device is lightweight and portable able to be worn comfortably by a post-surgical female patient following breast reconstruction or augmentation surgery;
2. The breast compression device is easy to put on and remove by a post-surgical patient whose strength and arm mobility may be limited for an indefinite period following surgery;
3. The breast compression device includes a strap mechanism or harness for supporting the weight of the device, holding the device firmly against the chest wall so that compression occurs at the base of the breast, and preventing shifting between compression cycles;
4. The compression members are able to prevent the breast implant from moving out of position while applying pressure to the breast;
5. The breast compression device includes an electronic control module and either rechargeable battery or AC transformer;
6. The breast compression device is adjustable to fit any size user;
7. The breast compression device includes Operating and Low Battery indicators;
8. The breast compression device includes a Power ON/OFF Switch; Pressure Set Switch allowing setting of maximum desired breast pressure by patient slowly until desired level of pressure is reached; a Session Start Switch for starting 15 minute sessions during which pressure is automatically increased until a desired level is reached, holding pressure for the required time, and then reliving; and a stop switch able to terminate the session and remove pressure from the breast which is selectively operated if patient feels pain
Safety Features
1. The device exerts forces on the breast, which are less than the forces that may result in rupturing a breast implant. Redundant pressure monitoring and control means ensure that a single fault does not result in a hazard to the user. ASTM F703: Standard Specification for Implantable Breast Prostheses is used as control guidance with respect to acceptable forces to apply;
2. The breast compression device is safe to use at home by the patient;
3. The breast compression device terminates the session if the preset (not user-adjustable) maximum pressure limit is exceeded;
4. The breast compression device terminates the session upon activation of the stop switch by the patient;
5. The breast compression device contains Microprocessor Monitor (watchdog);
6. Low voltage system: AC transformer or rechargeable battery;
7. The breast compression device complies with FDA Design Control Requirements and Regulations; and
8. The breast compression device complies with domestic and international safety standards for electromechanical medical devices including, but not limited to. IEC 60601: Medical Electrical Equipment, General Requirements for Safety.
A device for compressing a breast. The device includes a harness able to be releasably secured to a body of a user and a compression member adjustably connected to the harness for receiving the breast of the user. A control module is releasably secured to the harness for providing a pressure to the compression member for applying an equal compression force to the breast. The compression member includes a first compressing element positioned on a first side of the breast; a second compression element positioned on a second side of the breast opposite the first compressing element; and a structural member extending between the first and second compressing elements for retaining the first and second compressing elements on respective sides of the breast whereby an aperture defined by the structural member and first and second compressing elements for receiving the breast therein. The harness includes a first strap for securing the device about a waist of the user and a shoulder strap adjustably connected to the first strap for retaining the compression member aligned with the breast of the user. The structural member includes a first length adjustable structural element extending between a first end of both the first and second compressing elements and a second length adjustable structural member extending between a second end of both the first and second compressing elements. The control element includes a pump and supply line connected between the pump and both the first and second compressing elements for providing air pressure thereto.
To the accomplishment of the above and related objects, this invention may be embodied in the form illustrated in the accompanying drawings, attention being called to the fact, however, that the drawings are illustrative only, and that changes may be made in the specific construction illustrated and described withing the scope of the appended claims.